1. Field of the Invention
The present invention relates generally to acrylic polymers which have been modified to resist the degrading effect of sterilizing radiation and, in particular, sterilizing gamma radiation. More specifically, the present invention relates to acrylic polymers admixed with a particular additive or additive combination, which show good chemical resistance, as well as maintenance of optical properties and minimal yellowing on exposure to sterilizing radiation.
2. Description of Related Art
Acrylic polymers based on methyl methacrylate, including impact modified forms, are transparent, processible and possess a number of other physical and chemical properties making them suitable for use as molding resins for the production of a wide variety of useful articles. One such use is in the medical field for forming articles such as syringes, spikes, connectors and luers, suction devices, urine meters, blood plasma separators, drip chambers, cuvettes, dialyzer casings, chest drainage units, bottles for fluids, vaginal speculums, flow valves, aspirators, containers for operating instruments, and the like.
Prior to their use or re-use, these medical articles require sterilization which is commonly accomplished, for example, by exposing the article to low levels of gamma radiation. Doing so, however, induces yellowing and loss of light transmission in the article which alters the appearance in an aesthetically unfavorable way.
One attempt to solve the yellowing problem has been to add to the resin various conventional polymer stabilizing additives such as antioxidants, ultraviolet light absorbers and hindered amines. These conventional stabilizing additives, however, have not in and of themselves been found to effectively control discoloration induced by sterilizing gamma radiation. In addition, the use of such additives may have a detrimental effect on the transparency of articles formed from such resins.
Another proposed solution is described in U.S. Pat. Nos. 102940, 5216060, 5250589 and 5258423, all of which are incorporated by reference herein for all purposes as if fully set forth. In these patents, small amounts (up to 2 wt %) of lower molecular weight alcohols and alcohol derivatives, and particularly aliphatic alcohols and .alpha.-hydroxy acids containing up to 10 carbon atoms, as well as ester derivatives thereof, are utilized as additives. Higher molecular weight compounds, and even only slightly higher molecular weight alcohols and ester derivatives such as stearyl alcohol and butyl stearate, are stated not to be effective in promoting resistance to color formation by sterilizing radiation.
While the lower molecular weight additives described in these patents do appear to reduce the gamma radiation induced yellowing of acrylic polymers, their use has not been found to be entirely satisfactory. For example, the use of the lower molecular weight additives (such as butyl lactate) can present handling and processing difficulties in that they are generally liquid, have a tendency to volatilize under common processing conditions, and often have stringent limitations as far as toxicity. In addition, the use of some of these lower molecular weight additives may adversely affect the physical and chemical resistance properties, as well as the optical properties, of the final resin.
An acrylic polymer composition has now been discovered which is not only resistant to gamma radiation induced yellowing but also overcomes many of the defects associated with the aforementioned systems incorporating the lower molecular weight additives.